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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024942
Receipt No. R000028694
Scientific Title Venous Thromboembolism (VTE) in Cancer Patients;a Multicenter Prospective Registry
Date of disclosure of the study information 2017/02/10
Last modified on 2019/01/29

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Basic information
Public title Venous Thromboembolism (VTE) in Cancer Patients;a Multicenter Prospective Registry
Acronym Cancer-VTE Registry
Scientific Title Venous Thromboembolism (VTE) in Cancer Patients;a Multicenter Prospective Registry
Scientific Title:Acronym Cancer-VTE Registry
Region
Japan

Condition
Condition colon cancer, lung cancer, gastric cancer, breast cancer, gynecologic cancer, pancreatic cancer
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Pneumology
Gastrointestinal surgery Hepato-biliary-pancreatic surgery Chest surgery
Breast surgery Obsterics and gynecology Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study is intended to clarify the frequency of intercurrent of venous thromboembolism (VTE), actual condition of VTE treatment and its prognosis and to identify background factor related with VTE events in cancer patients, in addition clarify optimal medical attention population and usage for Direct Oral Anti Coagulant (DOAC) treatment.
Basic objectives2 Others
Basic objectives -Others Evaluate a variety of clinical questions between cancer and VTE
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes (1) Baseline
frequency of intercurrent of VTE at the time of VTE screening
(2) Observation period (one year)
incidence of symptomatic VTE
incidence of bleeding events
Key secondary outcomes Incidence of brain infarction/ systemic embolism
Survival
VTE related mortality rate and bleeding related mortality rate
Brain infarction related mortality rate and systemic embolism related mortality rate

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1)20 years old or older at written informed consent.
(2) Diagnosed with any one of the following: colorectal cancer, lung cancer (small cell lung cancer, and non-small cell lung cancer), gastric cancer, breast cancer, gynecological cancer (endmetrial cancer, cervical cancer, ovarian cancer, fallopian tube cancer, and peritoneal cancer), or pancreatic cancer (both initial and/or recurrence). Except active double cancer (synchronous double cancer, and metachronous double cancer with a disease-free period within 5 years) patients but patients with intramucosal cancer can be enrolled.
(3) Planned to undergo drug therapy (chemotherapy, hormone therapy, targeted molecular therapy, and immune checkpoint inhibitor therapy), radiation therapy or surgery. For recurrence cases, patients who received drug therapy (chemotherapy, hormone therapy, targeted molecular therapy, and immune checkpoint inhibitor therapy), radiation therapy or underwent surgery at initial occurrence can be enrolled.
(4) Carried out VTE screening (lower extremities venous ultrasound) within 2 months before enrollment and before the cancer treatment. If D-dimer value after the diagnosis of cancer is <=1.2 microgram/mL, VTE screening is not required.
(5) Stage II to IV; for gynecological cancer, Stage I to IV and for lung cancer, Stage IB to IV.
(6) Expected survival after enrollment must be >=6 months; for pancreatic cancer, >=3 months.
(7) Eastern Cooperative Oncology Group (ECOG) Performance Status grade must be 0-2; for pancreatic cancer, 0-1.
(8) Informed consent in writing given freely by the patients themselves for participation in the survey of this study.
Key exclusion criteria A patient who is inappropriate as a subject of the study judged by investigator.
Target sample size 10000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuo Ohashi
Organization Chuo University
Division name Department of science and engineering
Zip code
Address 1-13-27Kasuga Bunkyoku Tokyo
TEL 03-3817-1715
Email ohashiy.00e@g.chuo-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Cancer-VTE Registry Secretariat
Organization J-CRUSE
Division name Department of Clinical Research Promotion
Zip code
Address 6-29 Ogawacho Shinjukuku Tokyo
TEL 03-5946-8264
Homepage URL
Email vte@j-crsu.co.jp

Sponsor
Institute Medical Science Department
Daiichi Sankyo Company, Limited.
Institute
Department

Funding Source
Organization Medical Science Department
Daiichi Sankyo Company, Limited.
3-5-1 Nihonbashi-honcho
Chuo-ku, Tokyo 103-8426
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 国立がん研究センター中央病院(東京)、国立がん研究センター東病院(千葉県)、大阪府立成人病センター(大阪)、国立病院機構大阪医療センター(大阪)、兵庫医科大学(兵庫)、日本赤十字社医療センター(東京)、埼玉医科大学国際医療センター(埼玉)他約150施設

Other administrative information
Date of disclosure of the study information
2017 Year 02 Month 10 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2016 Year 11 Month 11 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Multicenter Prospective Registry

Management information
Registered date
2016 Year 11 Month 22 Day
Last modified on
2019 Year 01 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028694

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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